Medical Device Regulation

Produced in partnership with Iberian Lawyer.

Substantial investment in new technologies has recently led to significant innovations in the healthcare sector, with the major beneficiaries being patient health and efficiencies in the provision of healthcare services. In fact, the investment in the development of new health products and techniques with resource to technology plays a crucial role in healthcare innovation.

Whilst is unquestionable that safety should be a key concern in the scope of new products and techniques, an effort to achieve a balance in relation to the impact of the regulatory solutions from a cost of compliance and operational standpoint is also of major importance.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (the MDR), which will apply from May 2021, aims to “ensure a high level of safety and health whilst supporting innovation”.

To that end, the MDR increases the requirements applicable to medical device manufacturers and remaining supply chain operators aiming the implementation of high security standards, notably by the reinforcement of legal obligations regarding placement of medical devices on the market and an effective post-market surveillance.

The implementation of the changes and level of detail brought to Portuguese medical device’s legal framework is having a significant impact on medium and small companies already operating in the medical devices sector (which traditionally have a strong engagement in innovation), as well as on certain companies not covered by the medical devices legal framework until the MDR was implemented.

In fact, the MDR increases the range of products considered to be “medical devices” and which will therefore fall within its regulatory scope. For example, products that are claimed to have a “non-medical purpose” may now be subject to the MDR to the extent they are “similar to medical devices in terms of functioning and risks profile”.

Similarly, medical devices sold at distance and those not placed on the market but used in the scope of a commercial activity to provide diagnostic or therapeutic services to an EU company/citizen in the context of a commercial activity and offered by means of information society service or by other means of communication, must also comply with MDR requirements.

This enlarged regulatory scope, along with provisions such as those applicable to the reprocessing of single-use devices, under which any natural or legal person reprocessing a single-use device for further use in the Union shall be considered to be the manufacturer of the reprocessed device, means an increase in the number of entities qualifying as “medical device manufacturers” for purposes of the MDR and, consequently, subject to its compliance.

Furthermore, the MDR also requires medical device manufacturers to implement new (and more detailed) safety procedures. In addition to the detailed post-market surveillance system, manufacturers will need to assign a Unique Device Identification (UDI) to its medical device products for purposes of traceability. The UDI must be included in the device’s technical documentation, on its labelling, and, whenever possible, in the medical device itself. This will improve post-market surveillance efficiency by allowing to identify a specific medical device placed on the market.

Moreover, and with substantial impact on manufacturers of medical devices incorporating software, the MDR provides for significant requirements and conditions in order to ensure IT networks security.

These and other regulatory changes requiring implementation, generate considerable costs of compliance and significant operational challenges. In fact, the effort and resources needed to respond to the regulatory obligations – ranging from an accurate evaluation of the MDR requirements and conditions and an exhaustive review of products portfolio, to the investment on human resources and on building an effective implementation strategy – is revealing to be excessively burdensome for certain entities.

While increased requirements on safety and transparency resulting from a harmonized regulatory system are essential to ensure patient and public health, mainly when they are aimed to solve previous relevant problems, it is also of major importance not reduce innovation, by forcing companies to take divestment decisions regarding relevant products due to the operational and financial impact.

After all, the MDR intends to support and integrate innovation arising in healthcare sector, not preventing innovative contributions from entering the market.